MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM

Model Number	400CE
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was evaluated at the facility by a gentherm technician on 03/23/2021.The f3 and f4 fuses on the power board had overheated.Power board, cpu board, heater and membrane panel replaced.Parts have returned and evaluation is pending.
Event or Problem Description
Customer reported that the hemotherm 400 ce had an issue during a case."the hemotherm started to smoke and filled the cardiac or with smoke and a very noxious odor.Biomed swapped out the unit and determined that it was the power supply board.".

• Brand Name: HEMOTHERM
• Common Device Name: HEMOTHERM
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• MDR Report Key: 11985996
• Report Number: 1516825-2021-00004
• Device Sequence Number: 11600200
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K122813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1